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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K952412
Device Name DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
Applicant
Dupont Medical Products
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Applicant Contact REBECCA S AYASH
Correspondent
Dupont Medical Products
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact REBECCA S AYASH
Regulation Number862.3280
Classification Product Code
DIF  
Date Received05/23/1995
Decision Date 06/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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